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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K895819
Device Name MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL
Applicant
Medi-Tech, Inc.
26 Court St.
Brooklyn,  NY  11242
Applicant Contact HERBERT A PERRY
Correspondent
Medi-Tech, Inc.
26 Court St.
Brooklyn,  NY  11242
Correspondent Contact HERBERT A PERRY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/29/1989
Decision Date 11/02/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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